The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Yasmeen Rahimi - Piper Sandler - Analyst
: Good morning team. Congrats on all the updates and congrats, Greg, for joining a wonderful company and look very much forward to working
closely with you. Team, really exciting that you got the VELOCITY studies aligned with the agency and kicking it off. I guess the question that we
have for you is, now that you have the alignment, how important was the alignment in terms of strategic discussion and partnership? That's sort
of question one.
Question two, are you still planning to -- if you're planning to kick off the studies, would they be occurring in a sequential order or at the same
time?
And then the third question is, if you could shed some light on what are these additional indications you're potentially considering for which you're
filing INDs, that would be helpful. And I'll jump back into the queue.
Thank you.
Question: Yasmeen Rahimi - Piper Sandler - Analyst
: Thank you so much. I'll jump back in the queue.
Question: Liisa Bayko - Evercore ISI - Analyst
: Hi, thanks for taking the question. Congrats on all the progress. Sort of two line of questions for me. First of all, I guess, as it relates to cardiac safety,
do you think FDA views this as a class effect? And it might be something that sort of comes up as you talk about -- go back to FDA and discuss the
fuller Phase 3 program, including MASH, which I think is what you intend to sort of prioritize yourselves. I'm just curious about that. Or is this
something where they've seen something specific in the survodutide data? It just seems to me with the ratio that they have versus the ratio you
have and the fact that you do have quite a bit of glucagon, I'm wondering if that's something that kind of gets revisited.
And then curious about the timing of the additional indications, really interesting concept. Are you going to wait for data from -- in MASH before
initiating those and really taking off or when should we expect to learn more about that? Thanks.
Question: Liisa Bayko - Evercore ISI - Analyst
: One quick follow-up. Just can you remind us for survodutide, were those signals that they saw the increase in heart rate and all those things, were
they early events or late events? In other words, do they happen after six months or earlier in the study?
Question: William Wood - B. Riley Securities, Inc. - Analyst
: Hi, good morning team. This is William on for, for Miami. Thanks for taking our questions and congratulations on the great quarter and and
congratulations on the recently hiring of Greg. We have a couple of questions digging a little bit deeper, just kind of curious about the phase three
essence data that we will be expecting at a sld coming up. I guess maybe what are you looking for specifically in that data that really could help
provide or inform your confidence in your ongoing phase to impact study? Any any extra insight there could be could be helpful and then I have
a follow up.
Question: William Wood - B. Riley Securities, Inc. - Analyst
: And then an additional question on your strategic partnerships. These have been going on for a little while now, beginning around the end of your
Phase 2 MOMENTUM readout. I'm just kind of curious how your discussions with potential partnerships have evolved over time now that we're
getting closer to Phase 2 impact, obviously, ESSENCE readout and now your three additional indications. Any color on the evolving conversation
and if they're now starting to expand across multiple -- the broader potential of pemvidutide, any color on that would be helpful.
Question: William Wood - B. Riley Securities, Inc. - Analyst
: Got it very helpful. I'll hop back in the queue and congrats again on a very nice quarter.
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